Summary

The purpose of this study is to understand the effectiveness of a ten-week internet-based
cognitive behavioral therapy (iCBT) treatment on improving depressive symptoms, coping and
resilience skills, and cognitive processing.

Eligibility Criteria

Male or female participants from 18 years up to 45 years old.

Inclusion criteria:
- Age range between 18 and 45.
- Subjects must be right handed (as measured by Edinburgh Handedness Inventory).
- The primary language of the subjects must be English
- Must have regular access to a computer with internet connection and printer (for
potential MDD or MAC participants)
- DSM-IV criteria for current Major Depressive Episode according to SCID (for
enrollment into MDD or MAC groups)
- Absence of any psychotropic medications for at least 2 weeks (6 weeks for fluoxetine;
6 months for neuroleptics; 2 weeks for benzodiazepines; 2 weeks for any other
antidepressants)
- PHQ-9 score below 5 (for enrollment into HC group)
Exclusion criteria:
- Any history of neurological illness or brain injury
- Current or past DSM-IV Axis I disorder (for enrollment into HC group)
- Complicating medical conditions that may influence the outcome of neuropsychological
assessment or functional imaging (e.g., HIV)
- Mixed or left-handedness
- Abnormal visual acuity that is not corrected by contact lenses
- Metal within the body, claustrophobia, or other contraindications for MRI
- Less than 9th grade education
- Past or current alcohol/substance dependence, or current alcohol abuse, or current or
past substance abuse (i.e. past alcohol abuse is not exclusionary)
- Use of illicit drugs within the past year
- Use of marijuana within the past month
- Current use of opioid or prescribed stimulant medications
- History of a psychotic mental illness (schizophrenia or bipolar disorder)
- Current severe symptoms of depression (total score > 23 or responding > 1 to Question
9 for suicidal ideation in the Patient Health Questionnaire-9 Item [PHQ-9] (Kroenke
et al., 2001))
- A PHQ-9 score below 10 (for potential MDD or MAC participants)
- Currently participating in Cognitive Behavior Therapy
- History of ECT treatment

Additional Information

The need for mental health services is high among military personnel but perceived stigma
and other barriers prevent many Soldiers from obtaining the help they need. Alternative
mental health treatment approaches that mitigate stigma and increase access and compliance
are greatly needed. One promising treatment approach that has shown efficacy in preliminary
research and which may address issues related to stigma and barriers to care, is
internet-based cognitive behavioral therapy (iCBT). Internet-based treatments offer brief,
interactive, and structured treatment approaches that can be completed by individuals
relatively anonymously, in the convenience and privacy of their own homes, and according to
their own schedules. Such interventions could offer Soldiers an alternative treatment method
that minimizes stigma by allowing private and quasi-anonymous access to treatment and which
minimizes barriers to care by enhancing access and maximizing schedule flexibility.
Emerging evidence suggests that iCBT is a particularly promising and well-accepted approach
for treating large numbers of individuals while minimizing cost and clinicians' time demand.
The study of internet-based and other computer-assisted therapies is currently in its
infancy and most studies still lack sufficient methodological rigor to firmly establish the
efficacy and applicability of these approaches. The proposed project will provide the most
comprehensive evaluation of iCBT to date by employing functional neuroimaging techniques,
neurocognitive testing of implicit negative biases and responses to negative feedback, and
assessment of resilience and coping capacities in addition to standard symptom-based outcome
measures.

Trial information was received from ClinicalTrials.gov and was last updated in March 2016.